A nurse led psychosocial intervention with peer support to reduce psychosocial needs in women with gynaecological cancer

In patients with gynaegological cancer being treated curatively with radiotherapy, does a nurse led psychosocial intervention compared to usual care decrease psychosocial needs?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000312246

Enrollment

Registered

2009-05-15

Start date

2010-01-21

Completion date

2010-04-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study involved the development and pilot / phase I testing of a psychoeducational intervention involving tailored nursing consultations combined with peer telephone support to address the psychosocial needs of women with gynaecological cancer being treated with radiotherapy. The intervention was found to be feasible and acceptable to patients and clinicians. This intervention was then further modified and is being tested in a larger RCT to identify whether the support program reduces psychological distress, unmet supportive care needs, psychosexual difficulties, and improves quality of life and adherence to dilator use. The ACTRN is the initial development & pilot testing phase is: ACTRN12609000312246. A second ACTRN is for the phase III trial for which this study was the initial development & pilot testing phase has also been submitted: ACTRN12611000744954.

Interventions

This pilot / Phase I study aimed to develop a nurse-led psychosocial intervention with peer support to reduce anxiety, psychosocial and psychosexual needs and symptom distress of women receiving radiotherapy for gynaecological cancers. The intervention consists of 3 nurse consultations (pre-treatment, mid-treatment, end-of-treatment); 5 peer support consultations (phone) (pre-treatment, mid-treatment, end-of-treatment, 2 and 4 weeks post-treatment). The overall duration of the intervention is ap

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

a confirmed diagnosis of gynaecological cancer; scheduled to receive radiotherapy with curative intent to the pelvis; aged 18 years or older; able to read and write English; and give informed consent.

Exclusion criteria

Exclusion criteria are a severe psychiatric or cognitive disorder; treatment with palliative intent; or previous treatment with radiotherapy.

Outcome results